GlaxoSmithKline —
Paroxetine
Patent Application 117035 · the “disappearing polymorph” dispute
Unipharm opposed GSK’s application concerning an anhydrous crystalline form of paroxetine hydrochloride and a process for producing it.
THE ISSUE
Can a previously known polymorph become patentable because it allegedly “disappeared”?
The case examined GSK’s theory that the anhydrous form had ceased to be obtainable by the earlier process and later “reappeared” through a new process. The proceedings required detailed scientific evidence concerning polymorphism, seeding and reproducibility.
The Deputy Registrar rejected the claim that the previously known material had become new and also addressed GSK’s failure to disclose material documents to the Patent Office.
Unipharm’s opposition was accepted.
The application was held not patentable. The decision became final after the contemplated appeal did not proceed.
Israel Patent Office Opposition to Patent Application 117035 · decision of 16 April 2009 Read decision (PDF) →